Webinar welcomes national standards body for support on navigating new legislation
A free webinar has encouraged medical device innovators to learn more about new Post-Market Surveillance (PMS) legislation and how to successfully navigate it.
Hosting the educational session on Wednesday, June 25 – entitled ‘ The new Post-Market Surveillance legislation for medical devices - what you need to know’ – formal NHS Scotland partner InnoScot Health believes it was a key opportunity to better understand the changes for Great Britain.
The changes are intended to improve the safety of medical devices – including in vitro diagnostics (IVD) and active implantable devices – while providing certainty for manufacturers.
Part of wider regulatory reform, the amended regulation will, the Medicines and Healthcare products Regulatory Agency (MHRA) says, “introduce clearer and more risk-proportionate PMS requirements”.
The ‘lunch and learn’ webinar was presented by Head of Regulatory Affairs Elaine Gemmell, who provided an overview of the complexities of the current landscape and outlined why it is vital to receive professional advice in order to navigate it successfully.
She was joined by guest speakers from The British Standards Institution (BSI) – Damon Williams, Sales Manager – Medical Devices, UK & Ireland, and Umar Butt, Business Development Manager, North UK and Ireland.
The national standards body of the United Kingdom, BSI is recognised through a Memorandum of Understanding with the UK Government, producing technical standards on a wide range of products and services.
They spoke on the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR and anticipated changes.
Elaine said: “Our June webinar was an opportunity to gain a more in-depth understanding of what is crucial new legislation for medical device manufacturers.
“Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal.
“But clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards.
“In response, we now have an important amendment this month and manufacturers are advised to learn more.
“We believe attendees found it useful and instructive in taking practical steps.”
The webinar was rounded off by an opportunity to ask questions of the speakers.
The medical device industry has experienced unprecedented growth over recent years, and changes to the regulatory landscape mean it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.
InnoScot Health has a strong record of protecting those interests.